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ClinicalTrials.gov Identifier: NCT01267994

Recruitment Status
:
Completed

First Posted
: December 29, 2010

Results First Posted
: April 6, 2015

Last Update Posted
: January 10, 2018

Sponsor:

Andrea Vambutas

Collaborator:

National Institute on Deafness and Other Communication Disorders (NIDCD)

The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED) that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thresholds following corticosteroid therapy.

Condition or disease

Intervention/treatment

Phase

Sensorineural Hearing LossAutoimmune Inner Ear Disease

Drug: Anakinra

Phase 1Phase 2

Detailed Description:

Patients with immune mediated hearing loss (also known as autoimmune hearing loss) are typically treated with corticosteroids. Of those treated, approximately 60% respond, however, that response may be lost over time. Other therapies use to date have proven largely ineffectual in improving hearing. This study proposes a phase I open label clinical trial of Anakinra for corticosteroid-resistant patients to determine if this therapy is efficacious in hearing restoration.

To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease [ Time Frame: 180 days ]

The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.

Secondary Outcome Measures
:

Number of Serious Adverse Events Reported [ Time Frame: 84 days ]

To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra

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Ages Eligible for Study:

13 Years to 75 Years (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Bilateral sensorineural hearing loss with an active decline in hearing in one ear

No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days